India grants Pfizer patent for blockbuster brand Prevenar 13

India has seven pneumonia related deaths per 1,000 live births, according to the 2016 Pneumonia and Diarrhea Progress Report.

Prevenar 13 is approved to prevent pneumococcal pneumonia and invasive pneumococcal diseases caused by 13 strains of streptococcus pneumonia, according to Pfizer.

NEW DELHI: India has granted US drug giant Pfizer a patent for its blockbuster Prevenar 13, a vaccine that helps prevent cases of pneumonia, one of the leading causes of deaths of children under five years of age. The approval comes more than a decade after the company applied for the patent in the country.

Global medical humanitarian organisation Médecins Sans Frontières (MSF) said it is a “major setback” to hopes for an affordable vaccine and is likely to legally challenge the patent approval.

This vaccine and GlaxoSmithKline's Synflorix are the only two pneumococcal conjugate vaccines (PCV) available in the country.

In the private market, Prevenar 13 is priced at Rs 3,800 per dose, and Synflorix at Rs 1,800 per dose, industry insiders said. Three doses are required for each child, they said.

Pneumonia killed nearly a million children under the age of five years in 2015 alone, according to the World Health Organisation. India has seven pneumonia related deaths per 1,000 live births, according to the 2016 Pneumonia and diarrhoea Progress Report by John Hopkins Bloomberg School of Public Health.

Pfizer subsidiary Wyeth internationally applied for a patent for Prevenar 13 in 2006 and its application was opposed by Indian vaccine maker Panacea Biotec and MSF over the years. Panacea is developing its own version of the vaccine, while MSF procures and provides Prevenar 13 to children in developing regions as part of its immunisation campaigns.

Panacea and MSF claimed Pfizer’s vaccine lacked the novelty for it to be considered for a patent.

India’s patent office, in its approval granted on August 11, dismissed these arguments. Pfizer has demonstrated “surprising effects” that have to be considered as establishing that its vaccine is inventive, it said.

A Pfizer spokesperson said, “We are pleased to note that the validity of the Prevenar 13 patent has now been recognized by the Indian Patent Office.”

The company said the patent is valid in India until 2026.

Each dose of Prevenar 13 requires 400 different raw materials, 580 manufacturing steps, 678 quality tests and 2.5 years to produce, the Pfizer spokesperson told ET. There has not been any price increase for this vaccine since its launch in India in 2010 even though regulations allow for annual price increases, the person said.

Prevenar 13 was included in India’s national immunisation programme this March and the vaccines are supplied at a subsidised rate by Gavi, the Vaccine Alliance. Around five states (approximately 5.15 million babies) are expected to be covered in the first phase.

MSF said Prevenar 13 is too expensive and that the grant of patent would restrict Indian manufacturers from producing and supplying an affordable vaccine.

Leena Menghaney, South Asia Head for MSF’s Access Campaign, said the organisation hoped to challenge the patent legally. “The method Pfizer is trying to patent is too obvious to deserve a patent under Indian law, and is just a way to guarantee an extended market monopoly for the corporation for many years to come,” she said.

The patent would prevent immunisation of a majority of India’s population because the country would have to bear the cost of each dose once Gavi phases out funding, Menghaney argued.

The pneumonia vaccine accounts for almost half the total cost of vaccinating a child in the poorest countries, according to MSF. Gavi supplies Prevenar 13 for India’s immunisation programme at around $10, or about Rs 641, for all three doses.

Prevenar 13 has captured 18% of the Indian vaccine market, according to Pfizer’s 2016 annual report.

A GSK spokesperson said Synflorix has captured approximately 65% of India’s private PCV vaccines market and 35% of the overall private Indian vaccines market. It is priced almost 2.5 times lower than competing vaccines, the person told ET.

Panacea and Serum Institute, which has been working on a PCV 10 vaccine, reportedly expected to price their vaccines for as low as $6 (nearly Rs 400) for all three doses.

The private Indian vaccines market was valued at Rs 1,700 crore as per IMS Moving Annual Turnover data for March 2017. The Indian PCV vaccines market was valued at approximately Rs 400 crore in 2015 and was the highest among private vaccines, according to a report commissioned by the Confederation of Indian Industry (CII).

Pfizer’s patent application for Prevenar 13 has also been challenged in countries like South Korea, while its patent in Europe was revoked by the European Patent Office in 2014.

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